Data Support Specialist

Data Support Specialist

Responsible for the accurate and timely Data Tracking and/or Entry of data into clinical database/systems, including Data Clarification Forms (DCFs), ensuring accuracy and quality with guidance from line management and/or senior. All tasks should be performed in accordance to corporate quality standards, SOPs/Work Instructions/Guidelines, ICH-GCP and/or other international regulatory requirements.

The Data Support Specialist works under the guidance of their Line Manager and may receive additional direction/support from an experienced Data Support Specialist or Subject Matter Experts.

Tracking & Scanning

Track and scan CRFs received, as per the transmittal sheet provided for each study.

Filing and archiving of CRFs and/or eDATA onto USBs for shipping to sites, with interaction/supervision by line manager or assigned mentor.

Data Entry

Perform data entry quickly and accurately via the data entry interface into various Clinical Databases, within given timelines and first-time quality

Work closely with the Early Phase Clinical Unit (EPCU) to ensure clinical SOPs are followed regarding the Data entry process, where applicable

Perform hyperlinking of pdf CRFs, prior to archiving activity

Support in administrative tasks as per business needs of Data Management Department

Perform second pass entry QC (reconciliation) as part of Data Entry process

Training

Maintain training compliance as per Job Roles assigned, including On-the-Job training.

Deliver On-the-job training where needed/requested.

Address training needs, as per Development Goal/s identified.

Quality & Compliance.

Utilize appropriate TIME codes for the tasks and projects and maintain utilization level, as per business needs

Ensure first time quality and accuracy of data tracked or entered by compliance to all relevant SOPs, guidelines, trainings and best practices.

Prepare for and participate in audits and inspections for internal, sponsor, and regulatory agencies.

Skills:

• Good interpersonal, oral and written communication skills.

• Learning ability; swift understanding of technologies and new processes

• Demonstrates attention to detail and commitment to First Time Quality, including a methodical and accurate approach to work activities

• Good Time management skills, ability to plan & prioritize tasks in order to meet objectives and timelines, including a sense of urgency

• Good written and oral fluency in English.

Knowledge and Experience:

• Basic computer skills, including familiarity of Microsoft Office products (MS-Word, MS-Excel, Outlook)

• Some knowledge of medical terminology preferred

• Average typing speed (17 WPM)

Education:

Secondary Institution qualification (i.e. Grade 12, High School)